Nystatin (ointment)

Nystatin (ointment)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]

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Overview

Nystatin (ointment) is an antifungal, polyene antibiotic that is FDA approved for the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida [Monilia]albicans and other Candida species. Common adverse reactions include irritation on topical application.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Nystatin Ointment is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida [Monilia]albicans and other Candida species.

Dosing Information

• Nystatin Ointment should be applied liberally to affected areas twice a day or as indicated until healing is complete. Nystatin cream is usually preferred to nystatin ointment in candidiasis involving intertriginous areas; very moist lesions, however, are best treated with nystatin topical powder.

• This preparation does not stain skin or mucous membranes and provides a simple, convenient means of treatment.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Nystatin (ointment) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Nystatin (ointment) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Nystatin (ointment) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Nystatin (ointment) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Nystatin (ointment) in pediatric patients.

Contraindications

• Nystatin Ointment is contraindicated in patients with a history of hypersensitivity to any of its components.

Warnings

PRECAUTIONS

• Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.

• This preparation is not for ophthalmic use.

Adverse Reactions

Clinical Trials Experience

• Nystatin is virtually non-toxic and nonsensitizing and is well tolerated by all age groups including debilitated infants, even on prolonged administration. If irritation on topical application should occur, discontinue medication.

Postmarketing Experience

There is limited information regarding Nystatin (ointment) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Nystatin (ointment) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Nystatin (ointment) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Nystatin (ointment) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Nystatin (ointment) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Nystatin (ointment) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Nystatin (ointment) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Nystatin (ointment) in geriatric settings.

Gender

There is no FDA guidance on the use of Nystatin (ointment) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Nystatin (ointment) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Nystatin (ointment) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Nystatin (ointment) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Nystatin (ointment) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Nystatin (ointment) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Nystatin (ointment) Administration in the drug label.

Monitoring

There is limited information regarding Nystatin (ointment) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Nystatin (ointment) and IV administrations.

Overdosage

There is limited information regarding Nystatin (ointment) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Nystatin (ointment) Pharmacology in the drug label.

Mechanism of Action

• Nystatin is an antifungal antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. It probably acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components.

Structure

• Nystatin Ointment USP, for topical use only, contains 100,000 USP Nystatin Units per gram, in a polyethylene and mineral oil base. The structural formula is as follows:

Pharmacodynamics

CLINICAL PHARMACOLOGY

• Nystatin is an antifungal antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. It probably acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin is a polyene antibiotic that is obtained from Streptomyces noursei, and is the first well tolerated antifungal antibiotic of dependable efficacy for the treatment of cutaneous, oral and intestinal infections caused by Candida [Monilia]albicans and other Candida species. It exhibits no appreciable activity against bacteria.

• Nystatin provides specific therapy for all localized forms of candidiasis. Symptomatic relief is rapid, often occurring within 24 to 72 hours after the initiation of treatment. Cure is effected both clinically and mycologically in most cases of localized candidiasis.

Pharmacokinetics

There is limited information regarding Nystatin (ointment) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Nystatin (ointment) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Nystatin (ointment) Clinical Studies in the drug label.

How Supplied

Nystatin Ointment (100,000 USP Nystatin Units per gram) is a yellow ointment available as follows:

NDC 0168-0007-15 15 gram tube NDC 0168-0007-30 30 gram tube

E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 I20715H R08/11

1. 21

Storage

• Store at controlled room temperature 15°- 30°C (59°-86°F).

Images

Drug Images

{{#ask: Page Name::Nystatin (ointment) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER

NDC 0168-0007-15

FOUGERA®

NYSTATIN OINTMENT USP

100,000 USP Nystatin Units Per Gram

For Topical Use Only.

Not for Ophthalmic Use.

Rx only

CONTAINS: 100,000 USP

Nystatin Units per gram,

in a polyethylene and

mineral oil base.

NET WT 15 grams

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON NDC 0168-0007-15

FOUGERA® Rx only

NYSTATIN OINTMENT USP

100,000 USP Nystatin Units Per Gram

WARNING: Keep this and all

drugs out of reach of children.

For Topical Use Only.

Not for Ophthalmic Use.

NET WT 15 grams {{#ask: Label Page::Nystatin (ointment) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Nystatin (ointment) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Nystatin (ointment) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Nystatin (ointment) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Nystatin (ointment) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.